Device recall
Z-2733-2016: Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
FDA device recall · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Recall number (Z-number) | Z-2733-2016 |
|---|---|
| Recall event | 75028 |
| Product | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND |
| Product code | HBG |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2017 |
| 510(k) numbers | K961113 |
| FEI number | 1000138491 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database